ICU Archives - BioTuesdays

Feature

SeaStar Medical prepares for FDA approval of device targeting treatment of pediatric acute kidney injury

SeaStar Medical (NASDAQ: ICU) expects an FDA Approval Order in the coming months for the company's Selective Cytopheretic Device (SCD) Pediatric (SCD-PED) under a humanitarian device exemption (HDE).

October 31, 2023

Developments

SeaStar Medical’s Selective Cytopheretic Device deemed HDE-approvable by FDA

The FDA deemed SeaStar Medical’s (NASDAQ:ICU) Selective Cytopheretic Device (SCD) Pediatric (SCD-PED) to be approvable under a Humanitarian Device Exemption (HDE). The HDE exemption would apply to children weighing 10...

October 6, 2023

Developments

SeaStar Medical to begin AKI device study to reduce hyperinflammation in adults

The FDA approved SeaStar Medical’s (NASDAQ:ICU) investigational device exemption application to conduct a pivotal study evaluating the effectiveness of its Selective Cytopheretic Device (SCD) in reducing...

February 9, 2023

Feature

SeaStar Medical gears for Q1 FDA decision on device to reverse effects of hyperinflammation

SeaStar Medical (NASDAQ:ICU) expects an FDA decision in the first quarter on a humanitarian device exemption application to use its Selective Cytopheretic Device (SCD) to treat the life-threatening effects of...

January 10, 2023

Developments

SeaStar Medical completes merger with LMF Acquisition Opportunities

SeaStar Medical completed a business combination with LMF Acquisition Opportunities (NASDAQ:LMAO), a special purpose acquisition company sponsored by LM Funding America (NASDAQ:LMFA). The combined company was renamed...

October 28, 2022

Developments

LMF Acquisition holders approve merger with SeaStar Medical

Shareholders of LMF Acquisition Opportunities (NASDAQ:LMAO) voted at a special meeting to approve a business combination with SeaStar Medical, a medical technology company developing proprietary solutions to reduce the...

October 18, 2022

Tag - ICU

SeaStar Medical prepares for FDA approval of device targeting treatment of pediatric acute kidney injury

SeaStar Medical’s Selective Cytopheretic Device deemed HDE-approvable by FDA

SeaStar Medical to begin AKI device study to reduce hyperinflammation in adults

SeaStar Medical gears for Q1 FDA decision on device to reverse effects of hyperinflammation

SeaStar Medical completes merger with LMF Acquisition Opportunities

LMF Acquisition holders approve merger with SeaStar Medical

General

More